Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Close this folder1. National drug regulation
Close this folderGuiding principles for small national drug regulatory authorities1,2
Open this folder and view contents1. General considerations
Open this folder and view contents2. Administrative aspects of the licensing process
Close this folder3. Technical aspects of the licensing process
View the document3.1 General considerations
View the document3.2 Products containing long-established chemical entities
View the document3.3 Products containing new chemical entities
View the document3.4 Herbal products
View the document3.5 Combinations of potent, therapeutically active substances
View the document3.6 Generic products
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
3.1 General considerations

Although countries vary in their resources and priorities, advantage accrues from harmonizing documentary requirements to the fullest possible extent, since this simplifies registration procedures and reduces costs.

The most important starting-point for imported products is the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.1 This gives basic information on composition, an assurance that the product is manufactured in accordance with good manufacturing practices in premises subject to inspection, and information on the regulatory status of the product in the country of export. A certificate, issued in compliance with the model format recommended by WHO, should be required whenever application is made to license an imported product.

1WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-first Report. Geneva, World Health Organization, 1990 (WHO Technical Report Series, No. 790), Annex 5.

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